Cited by 151Thyroid Disorders and TreatmentsThyroid and Parathyroid SurgeryHormonal and reproductive studies

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The Starting Dose of Levothyroxine in Primary Hypothyroidism Treatment: A Prospective, Randomized, Double-blind Trial

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Roos, Annemieke, Linn-Rasker, Suzanne P., van Domburg, Ron T., Tijssen, Jan P., Berghout, Arie·2005·Archives of Internal Medicine

DOI 10.1001/archinte.165.15.1714

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Abstract

BACKGROUND: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. METHODS: We conducted a prospective, randomized, double-blind trial that compared a full starting levothyroxine dose of 1.6 mug/kg with a low starting dose of 25 mug (increased every 4 weeks) in patients with newly diagnosed cardiac asymptomatic hypothyroidism. Safety was studied by documenting cardiac symptoms and events, and efficacy was studied by monitoring thyrotropin and free thyroxine levels and by assessing improvement of signs and symptoms and quality of life. RESULTS: Seventy-five consecutive patients were enrolled, of whom 50 underwent randomization. At baseline, the severity of hypothyroidism and age were comparable in the full-dose (n = 25) vs the low-dose group (n = 25): thyrotropin, 61 vs 48 mIU/L; free thyroxine, 0.56 vs 0.64 ng/dL (7.2 vs 8.2 pmol/L); and age, 47 vs 47 years. No cardiac complaints or events were documented during treatment or at bicycle ergometry at baseline, 12 weeks, or 24 weeks. Euthyroidism was reached in the full-dose vs the low-dose group in 13 vs 1 (4 weeks), 19 vs 3 (8 weeks), 19 vs 9 (12 weeks), 20 vs 14 (16 weeks), 20 vs 18 (20 weeks), and 21 vs 20 (24 weeks) patients (P = .005). However, signs and symptoms of hypothyroidism and quality of life improved at a comparable rate. CONCLUSION: A full starting dose of levothyroxine in cardiac asymptomatic patients with primary hypothyroidism is safe and may be more convenient and cost-effective than a low starting dose regimen.

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Authors: Roos, A., Linn-Rasker, S. P., van Domburg, R. T., Tijssen, J. P., & Berghout, A.
Affiliations: Erasmus MC (NL)
Venue: Archives of Internal Medicine
Publisher: American Medical Association (AMA)
Published: 2005-08-08
Volume: 165
Issue: 15
Pages: 1714
ISSN: 0003-9926 (ISSN-L)
DOI: 10.1001/archinte.165.15.1714
OpenAlex: W2126532627
Cited by: 150
References: 49
Citations by year: 2026: 1 · 2025: 12 · 2024: 5 · 2023: 12 · 2022: 12 · 2021: 9 · 2020: 4 · 2019: 10 · 2018: 2 · 2017: 6 · 2016: 9 · 2015: 7 · 2014: 6 · 2013: 6 · 2012: 13
FWCI: 3.10
Type: journal article
Language: en
Open access: green
hdl.handle.net
Licence: other-oa
Locations: Archives of Internal Medicine (publishedVersion)
PubMed (publishedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
Pure Amsterdam UMC (submittedVersion)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
Keywords: levothyroxine, primary hypothyroidism, starting dose, euthyroidism, thyroid-stimulating hormone, free thyroxine, quality of life, hypothyroidism symptoms, treatment safety
MeSH terms: Adult, Aged, Double-Blind Method, Half-Life, Humans, Hypothyroidism, Male, Middle Aged, Prospective Studies, Quality of Life, Thyrotropin, Thyroxine

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The Starting Dose of Levothyroxine in Primary Hypothyroidism Treatment: A Prospective, Randomized, Double-blind Trial

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